Global Medical Device Updates
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Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
New FDA Guidance Emphasizes Gender Differences in Clinical Studies
New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.
The guidance aims to suggest methods to enroll more women in clinical studies in order to better represent demographic distributions of particular diseases; identify statistical analyses of study data that take into account gender differences; emphasize the need to consider gender differences during manufacturers’ study design phases; and spell out expectations of the Center for Devices and Radiological Health (CDRH) for reporting of sex- and gender-related information in study summaries and labeling for approved or cleared devices.
“Certain medical products elicit different responses in women compared to men,” the guidance states, citing ventricular assist devices and cardiac resynchronization therapy defibrillators as examples of devices with significant differences in effectiveness between male and female patients.
“Many clinical studies do not enroll proportions of women that reflect the underlying disease distribution in the affected population… This has contributed to a substantial lack of available data regarding the risks and benefits of medical device use in women.”
Historical barriers to enrollment of women in clinical studies, according to the FDA, include fears of fetal consequences, avoidance of female subjects by study sponsors, and study inclusion or exclusion criteria that inadvertently exclude women. To reduce these challenges, study sponsors and manufacturers should examine screening logs in order to track reasons for non-enrollment of women as subjects.
What to include in submission documents
The guidance recommends inclusion of information such as sex-specific prevalence of the disease in question, sex-specific diagnosis and treatment patterns, identification of proportions for women included in past clinical studies, and identification of any known clinically significant sex differences in outcomes regarding safety or effectiveness.
For new and ongoing studies, manufacturers and sponsors should include the afore-mentioned data as components of the risk analysis sections of their investigational plans. Firms should also summarize this information in their study protocols and training materials.
For completed studies, this data should be included as part of your marketing application under clinical investigation results. A draft PMA Summaries of Safety and Effectiveness or 510(k) Summary should also include this information.
Finally, for postmarket studies, this information should be included in interim reports as well as the results sections of final reports.
Other Recommendations
In addition, the FDA guidance recommends clinical study investigators take into account how the influence of subjects’ sex affects primary endpoints for safety and effectiveness. Analysis of subgroups and testing for interaction or heterogeneity may also be necessary, according to the agency.
Statistical analysis must also address sex-specific issues, recommends the FDA. Any clinically significant sex differences should be reported and discussed with FDA personnel to see whether further investigations are required based on those findings. Sex-specific information should also be reflected more thoroughly in study summaries and labeling, according to the guidance.
Markets: USATags: 501(k), 510k, clinical study, FDA, PMA, postmarket surveillance, premarket approval
Author: Stewart EisenhartDate: December 19, 2011
HC Amends Procedure for Mandatory Problem Reports
Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Program Reporting Program (CVMD), beginning October 3, 2011.
The change will impact firms with Medical Device Establishment Licenses and Canadian Medical Devices Conformity Assessment System accreditations.
Responsibility for HC’s MPR procedure has moved from the regulator’s Health Products and Food Branch Inspectorate to its Marketed Health Products Directorate. The CVMD falls under HC’s Canada Vigilance program for post-market surveillance of health products.
From October 3rd, device manufacturers and importers should send MPRs to the following address:
Canada Vigilance-Medical Device Problem Reporting
Marketed Health Products Directorate
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
Fax: 613.954.0941
Email: mdpr [at] hc-sc [dot] gc [dot] ca
HC is also updating associated documents—the Guidance Document for Mandatory Problem Reporting of Medical Devices (GUI-0059) and the Mandatory Problem Reporting Forms for Industry (FRM-0237, FRM-0238 and FRM-0255) in accordance with these procedural changes; the updated documents will be available on HC’s MedEffect website on October 3rd.
In the meantime, manufacturers and importers should continue submitting MPRs to the Health Products and Food Branch Inspectorate. For questions regarding the procedural change, firms should contact the Canada Vigilance program via email (canadavigilance [at] hc-sc [dot] gc [dot] ca) or phone (613.957.0337).
Markets: CanadaTags: CMDCAS, Health Canada, MDEL, MPR, post-market surveillance, postmarket surveillance
Author: Stewart EisenhartDate: September 16, 2011
FDA Proposes Longer Post-Market Surveillance Requirements for Pediatric Devices
New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding post-market surveillance requirements for pediatric products.
The guidance stems from changes made to Section 522 of the FDA Amendments Act of 2007 that authorize the FDA to order postmarket surveillance periods of longer than 36 months for Class II and III devices with significant pediatric applications; 510(k) clearance or PMA approval of those devices would be contingent upon meeting those postmarket surveillance requirements.
The FDA emphasizes that section 522 postmarket surveillance requirements apply not only to devices labeled for pediatric use, but also devices with off-label pediatric applications. The agency may order postmarket surveillance studies of durations longer than 36 months in instances where a device’s impact on growth and development needs to be assessed.
The FDA’s Center for Devices and Radiological Health (CDRH) has the authority to require postmarket surveillance studies at any point in a device’s lifecycle. The guidance lists several examples of when in the pre- or post-market process the CDRH may order surveillance:
- To confirm the nature, severity or frequency of issues contained in adverse event reports or published literature
- To gain more experience with a change in the device’s use from hospital to home settings, or with new patient populations
- To address long-term or infrequent safety and effectiveness questions regarding implantable devices and other products that premarket testing does not adequately cover
- To better define a device’s problems stemming from unexpected adverse events after that device’s marketing has begun
In the event that the CDRH orders a manufacturer to conduct a postmarket surveillance study, the guidance lists key elements to include in a study plan, including device description and indications for use, study purpose and objectives, design, and timelines. Guidelines for submitting interim and final study reports, as well as content and formatting requirements, are also covered.
Markets: USACategories: Regulatory ComplianceTags: CDRH, FDA, post-market surveillance, postmarket surveillance, section 522
Author: Stewart EisenhartDate: August 18, 2011
Health Canada’s Surveillance Process Found Lacking
Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection processes unsatisfactory, according to The Montreal Gazette.
The regulator’s poor review stems from its inadequate response to problems found in two previous audits as far back as 2004, the Gazette reports. Health Canada’s audit in October 2010 revealed that the regulator lacks awareness of what levels of surveillance and inspection are necessary to effectively monitor the Canadian medical device market and adequately support public safety. In addition, Health Canada doesn’t know if device risks its inspections have identified have been properly handled by manufacturers.
Auditors have recommended that Health Canada define levels of post-market activities required to properly safeguard public health, including establishment inspections, incident report reviews and keeping abreast of latest clinical and scientific literature.
But post-market shortcomings were not the only problems at Health Canada noted by auditors: The regulator has also failed to meet pre-market device review timelines in 45% of cases, delaying public access to new devices and technologies. While the regulator has contended that lack of proper funding has largely caused these delays, the Office of the General Auditor counters that Health Canada could more cost-effectively carry out its pre-market activities for devices previously approved in other markets by using data from those prior reviews in its assessments.
Markets: CanadaTags: Health Canada, Office of the Auditor General, postmarket surveillance
Author: Stewart EisenhartDate: June 10, 2011
Jaw Implants under FDA Scrutiny
Jaw implant manufacturers are apparently the latest segment of the medical device industry to experience the new get-tough stance by US regulators.
The three major manufacturers of temporomandibular joint (TMJ) implants in the US must perform new postmarket surveillance studies to address safety and device longevity concerns by the Food and Drug Administration (FDA).
The regulator has given firms TMJ Solutions, TMJ Medical and Biomet Microfixation 30 days each to submit study plans for approval prior to beginning their respective postmarket surveillances.
The FDA’s order follows an analysis the agency conducted of TMJ implant adverse event reports made between April 30, 2004 and August 17, 2010; although TMJ implant devices should have at least five-year life spans according to premarket testing, FDA investigators found that a “substantial number” of patients had their implants replaced within three years or less due to extreme pain.
Specific issues TMJ implant manufacturers must target through their postmarket surveillance studies include the length of time between a device’s initial implant and its removal; links between particular patient diagnoses and implant life span; and the life spans of replacement implants.
Manufacturers must also examine the reasons for implant removals and replacements; any associative factors between patient demographic and clinical data and rates of device removal; and assessments of implant devices that have been removed.
As of now, the FDA has not recommended any changes to the use of these devices, but manufacturers should nonetheless prepare for potential changes. The agency notes in its press release that TMJ implant manufacturers had already conducted postmarket surveillance on their devices during their initial approval processes, but those study results did not properly cover removal and replacement issues.
Possible moves the FDA is considering following the new postmarket surveillance of TMJ implants include labeling changes, new preclinical and clinical testing requirements and “other regulatory actions.”
